Early Neurophysiological Markers of Language Impairments

Development, Infant Clinical Trial

Official title:

Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants at Familial Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767242
• Other study ID #: 918
• Status: Recruiting
• Start date: February 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: IRCCS Eugenio Medea
• Contact: Chiara Cantiani, PhD
• Phone: +39031877924
• Email: chiara.cantiani[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present project aims at identifying very early electrophysiological risk markers for language impairments. The long-term goals of the study include the characterization of learning developmental trajectories in children at high risk for language impairments. In this project, all the infants of the Medea BabyLab cohort are followed-up until school age. Since these infants have complete information on early electrophysiological markers, the final goal of the project is the characterization of their learning developmental trajectories and the construction of a multi-factor prognostic model that includes the neurophysiological processes underlying basic-level skills as potential biomarkers for predicting later reading and spelling skills.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 8 Years

Eligibility

Inclusion Criteria:

• Healthy infants aged <24 months

• Infants with and without familial risk for language impairments (infants are assigned to the group with familial risk if at least one first-degree relative had a certified (clinical) diagnosis of language impairment or learning disability

• Both parents are native-Italian speakers

Exclusion Criteria:

• Gestational age < 37 weeks and/or birth weight < 2500 grams

• APGAR scores at birth at 1' and 5' < 7

• Bayley Cognitive Score < 7

• Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders, or autism within first-degree relative

Related Conditions & MeSH terms

• Development, Infant
• Developmental Language Disorder
• Language Development Disorders
• Language Disorders
• Learning Disabilities

Intervention

Other:
• Electrophysiological recording
Investigation of early neural markers using electrophysiology at 6-12-24 months

Behavioral:
• Behavioral assessment
Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)

Locations

Country	Name	City	State
Italy	Associazione La Nostra Famiglia - IRCCS Eugenio Medea	Bosisio Parini	LC

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expressive vocabulary at age 3 years	Standardized score in the Language Development Survey (Rescorla, 1989; Rescorla et al., 2014). Minimum=5; Maximum=95 (higher scores mean a better outcome).	Age 3 years
Primary	Phonological awareness at age 3 years	Raw score in a syllabic blending task (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).	Age 3 years
Primary	Syntactic comprehension at age 3 years	Standardized scores in the syntactic comprehension subtests, taken from 'Test for language evaluation', Cianchetti e Fancello, 1997. Z-scores are calculated (higher scores mean a better outcome).	Age 3 years
Primary	Lexical comprehension at age 3 years	Raw score in the lexical comprehension subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Scores are percentages of accuracy (higher scores mean a better outcome).	Age 3 years
Primary	Short-term verbal memory at age 4.5 years	Standardized scores in the pseudo-word repetition subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Z-scores are calculated (higher scores mean a better outcome).	Age 4.5 years
Primary	Phonological awareness at age 4.5 years	Standardized scores in the phonological awareness subtests taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).	Age 4.5 years
Primary	Phonological awareness at age 6 years	Composite score of the standardized scores in the phonological awareness subtests (phoneme identification, phonemic segmentation), Cornoldi et al., 2009. Z-scores are calculated (higher scores mean a better outcome).	Age 6 years
Primary	Letter identification, knowledge, and writing at age 6 years	Raw scores in the letter identification, knowledge, and writing subtests, taken from "Preschool Screening", Savelli et al., 2013. Minimum=0, Maximum=20 (higher scores mean a better outcome).	Age 6 years
Primary	Reading (accuracy, speed and comprehension) at age 8 years	Standardized scores in the reading subtest, taken from 'Reading and comprehension assessment', Bonifacci et al., 2014. Z-scores are calculated (higher scores mean a better outcome).	Age 8 years
Primary	Spelling at age 8 years	Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).	Age 8 years
Primary	Phonemic awareness at age 8 years	Raw scores in the spoonerisms subtest taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Minimum=0, Maximum=30 (higher scores mean a better outcome).	Age 8 years
Secondary	Lexical access at age 4.5 years	Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).	Age 4.5 years
Secondary	Naming and articulatory accuracy at age 3 years	Raw scores in the test of naming and articulatory accuracy (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).	Age 3 years
Secondary	Nonverbal cognitive score at age 4.5 years	Standardized score in the block design subtest, taken from 'Wechsler Preschool and Primary Scale of Intelligence, 3rd edition'. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).	Age 4.5 years
Secondary	Lexical access at age 6 years	Standardized score in Rapid Automatic Naming, taken from Urgesi et al., 2011. Z-scores are calculated (higher scores mean a better outcome).	Age 6 years
Secondary	Visual-motor integration at age 6 years	Standardized score in the 'Developmental Test of Visual-Motor Integration', Preda, 2000. Minimum=5; Maximum=95 (higher scores mean a better outcome).	Age 6 years